Phase
Condition
Gastroesophageal Reflux Disease (Gerd)
Gastroparesis
Esophageal Disorders
Treatment
Dexlansoprazole
Clinical Study ID
Ages 2-11 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
In the opinion of the investigator, the participant (as age appropriate) and/orparent(s)/legal guardian is capable of understanding and complying with protocolrequirements.
Prior to any study-specific procedures being performed, the appropriate informedconsent and the assent form(s) (as applicable) must be signed and dated by parent(s)or legal guardian and by the participant respectively, if appropriate.
Has a medical history of symptoms of GERD for at least 3 months prior to Screening.
Has met the eDiary qualification criteria as assessed by the PGSDD, defined ashurting or burning in the stomach, chest, or throat on at least 3 of any 7consecutive days during the Screening Period.
Has no evidence of erosive esophagitis (EE) according to the Los Angeles (LA)Classification of Esophagitis and, in the investigator's clinical judgment, thesymptoms are suggestive of acid-related disease. A 24-hour pH-metry (with or withoutimpedance) may be performed during Screening or within 6 months prior to Screeningfor similar symptoms as those identified during Screening if, in the investigator'sjudgment, this procedure would aid in the determination of whether the participant'ssymptoms are acid-related. An endoscopy performed within 1 week prior to signingscreening informed consent and assent form (as applicable) is an acceptablereplacement for the screening endoscopy if nonerosive GERD is confirmed,protocol-required biopsies were collected, and endoscopic pictures were obtained.
Is male or female and age 2 to 11 years, inclusive, at the time of screeninginformed consent.
Exclusion
Exclusion Criteria:
Has evidence of cardiovascular, pulmonary, central nervous system, hepatic,hematopoietic, renal, or metabolic disorder, severe allergy, asthma, or allergicskin rash that suggests any uncontrolled, clinically significant underlying diseaseor condition (other than the disease being studied), which may impact the ability ofthe participant to participate or potentially confound the study results.
Has a coexisting disease affecting the esophagus (eg, esophageal varices,scleroderma, viral or fungal infection, or esophageal stricture), history ofradiation therapy or cryotherapy to the esophagus, caustic or physiochemical traumasuch as sclerotherapy to the esophagus.
Has any findings in his/her medical history, physical examination, or safetyclinical laboratory tests giving reasonable suspicion of underlying disease thatmight interfere with the conduct of the trial.
Has a history of hypersensitivity or allergies to dexlansoprazole or any componentof the formulation of dexlansoprazole capsules, or any proton pump inhibitor (PPI) (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole) orantacids.
Is required to take excluded medications or it is anticipated that the participantwill require treatment with at least 1 of the disallowed concomitant medicationsduring the study evaluation period.
Has a condition that may require inpatient surgery during the course of the study.
Has a known history of Barrett's esophagus with dysplastic changes in the esophagus.
Has a known history of eosinophilic esophagitis (EoE) or histologic findingssuggestive of EoE (≥15 eosinophils per high-powered field [HPF]).
Has history of celiac disease, tests positive for tissue transglutaminase (tTG),antibody or confirmed disease by histology.
Has history of inflammatory bowel disease, or irritable bowel syndrome.
Has active gastric or duodenal ulcers within 4 weeks prior to Day -1. If present >4weeks prior to Day -1, ulcers must not be present upon screening endoscopy.
Requires dilatation of esophageal strictures and/or strictures preventing passage ofthe endoscope during the screening endoscopy. Schatzki's ring (a ring of mucosaltissue near the lower esophageal sphincter) is acceptable.
A female participant who has reached menarche by Day -1.
Is known to be positive for the human immunodeficiency virus (HIV).
Has current or historical evidence of Zollinger-Ellison syndrome or otherhypersecretory condition.
Has a history of gastric, duodenal, or esophageal surgery except simple oversew ofan ulcer. A history of gastric tube and/or percutaneous endoscopic gastrostomy (PEG)placement is allowed.
Had an acute upper gastrointestinal hemorrhage within 4 weeks prior to endoscopy.
Has donated or lost >10% of the total blood volume, undergone plasmapheresis, or hashad a transfusion of any blood product within 90 days prior to the first dose ofstudy drug.
Has a known history of alcohol abuse or illegal drug use within the past 12 monthsprior to the first dose of study drug.
Has any screening abnormal laboratory value that suggests a clinically significantunderlying disease or condition that may prevent the participant from entering thestudy; or the participant has: creatinine >1.5 mg/dL, alanine aminotransferase (ALT)and/or aspartate aminotransferase (AST) >2 times the upper limit of normal (×ULN),or total bilirubin >2.0 milligrams per deciliter (mg/dL) with AST/ALT elevated abovethe limits of normal values.
Is an immediate family member, study site employee, or is in a dependentrelationship with a study site employee who is involved in the conduct of this studyor may consent and assent (as applicable) under duress. Students of theinstitution/research facility who are under the supervision of, or in a subordinaterole to, the investigator are also ineligible.
The participant, in the opinion of the investigator, is unlikely to comply with theprotocol or is unsuitable for any other reason.
Has participated in another clinical study (not including screening for StudyTAK-390MR_205 [NCT02615184]) and/or has received any investigational compound within 30 days prior to Screening.
Study Design
Study Description
Connect with a study center
empty
Bruxelles,
BelgiumSite Not Available
empty
Montegnee,
BelgiumSite Not Available
empty
Passo Fundo, Rio Grande do Sul
BrazilSite Not Available
empty
Sao Paulo,
BrazilSite Not Available
Women and Children's Health Research Institute
Edmonton, Alberta T6G 1C9
CanadaSite Not Available
London Health Sciences Centre (LHSC) - Children's Hospital
London, Ontario N6A 5W9
CanadaSite Not Available
Hospital Universitario San Ignacio
Bogota, 110231
ColombiaSite Not Available
Centro Medico Imbanaco de Cali S.A
Cali, 760042
ColombiaSite Not Available
Fundacion Valle del Lili
Cali, 760032
ColombiaSite Not Available
empty
Afula,
IsraelSite Not Available
empty
Beer Sheva,
IsraelSite Not Available
empty
Beer Yaakov,
IsraelSite Not Available
empty
Haifa,
IsraelSite Not Available
empty
Jerusalem,
IsraelSite Not Available
empty
Ramat Gan,
IsraelSite Not Available
empty
Tiberias,
IsraelSite Not Available
empty
Napoli,
ItalySite Not Available
empty
Roma,
ItalySite Not Available
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, LT-50161
LithuaniaActive - Recruiting
Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos, Public Institution
Vilnius, LT-08661
LithuaniaActive - Recruiting
Boca Clinical Trials Mexico SC
Colonia Las Americas, Distrito Federal 1120
MexicoSite Not Available
empty
Mexico, Distrito Federal
MexicoSite Not Available
Clinical Research Institute S.C.
Tlalnepantla, Estado De Mexico 54055
MexicoActive - Recruiting
empty
Morelia, Michoacan
MexicoSite Not Available
Inspirepharma S. de R.L. de C.V.
Monterrey, Nuevo Leon 64660
MexicoSite Not Available
El Cielo Medical Center
Puebla, 72160
MexicoActive - Recruiting
SMIQ S. de R.L. de C.V.
Queretaro, 76070
MexicoActive - Recruiting
empty
Veracruz,
MexicoSite Not Available
In Vivo Osrodek Badan Klinicznych
Bydgoszcz, Kuyavia 85-048
PolandActive - Recruiting
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, Malopolskie 30-663
PolandSite Not Available
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warszawa, Masovia 04-730
PolandSite Not Available
Gabinet Lekarski Bartosz Korczowski
Rzeszow, Podkarpackie 35-302
PolandActive - Recruiting
empty
Worclaw,
PolandSite Not Available
empty
Braga,
PortugalSite Not Available
empty
Coimbra,
PortugalSite Not Available
empty
Lisboa,
PortugalSite Not Available
empty
Porto,
PortugalSite Not Available
University of South Alabama
Mobile, Alabama 36604
United StatesActive - Recruiting
empty
Phoenix, Arizona
United StatesSite Not Available
empty
Tucson, Arizona
United StatesSite Not Available
empty
Los Angeles, California
United StatesSite Not Available
University of California San Francisco
San Francisco, California 94158
United StatesSite Not Available
D&H National Research Centers
Miami, Florida 33155
United StatesActive - Recruiting
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia 30342
United StatesActive - Recruiting
empty
Chicago, Illinois
United StatesSite Not Available
University of Louisville
Louisville, Kentucky 40202
United StatesSite Not Available
empty
Shreveport, Louisiana
United StatesSite Not Available
Gastrointestinal Associates, PA
Flowood, Mississippi 39232
United StatesActive - Recruiting
empty
Jackson, Mississippi
United StatesSite Not Available
empty
Kansas City, Missouri
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
empty
Toledo, Ohio
United StatesSite Not Available
Measurable Outcome Research
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
GI for Kids
Knoxville, Tennessee 37922
United StatesActive - Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee 37212
United StatesSite Not Available
empty
Fort Worth, Texas
United StatesSite Not Available
empty
Houston, Texas
United StatesSite Not Available
Envision Clinical Research, LLC
Laredo, Texas 78041
United StatesActive - Recruiting
empty
Salt Lake City, Utah
United StatesSite Not Available
The Children's Hospital of The King's Daughters
Norfolk, Virginia 23507
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.